Status:
COMPLETED
CD19 CAR T-Cell Therapy for R/R Non-Hodgkin Lymphoma and Acute Lymphoblastic Leukemia
Lead Sponsor:
Vinmec Research Institute of Stem Cell and Gene Technology
Collaborating Sponsors:
National Institute of Hematology and Blood Transfusion, Vietnam
Conditions:
B-Cell Non Hodgkin Lymphoma
B-Cell Acute Lymphoblastic Leukemia
Eligibility:
All Genders
1-60 years
Phase:
PHASE1
Brief Summary
* Brief Summary: Cluster of differentiation 19 (CD19) is expressed on B cells. CD19+ tumor cells in patients with non-Hodgkin lymphoma and acute lymphoblastic leukemia can be targeted using T cells ex...
Detailed Description
Objectives: * Evaluate the frequency and severity of adverse events and serious adverse events (AEs/SAEs) of the therapy. * Evaluate the response rate after CD19 CAR T-cell infusion according to the ...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- B-cell acute lymphoblastic leukemia: refractory to two cycles of chemotherapy, relapsed after chemotherapy, or hematopoietic stem cell transplantation.
- B-cell non-Hodgkin lymphoma: refractory to two lines of chemotherapy, relapsed after chemotherapy, or hematopoietic stem cell transplantation.
- Age: From 1 to 60 years old (both males and females)
- Adequate organ functions:
- Serum creatinine ≤ 1.5 x ULN or eGFR ≥ 60 mL/min/1.73 m2
- ALT and AST ≤ 5 x ULN; Bilirubin ≤ 2.0 mg/dl
- No chronic lung diseases, such as obstructive pulmonary disease or bronchial asthma, required continuous medications without respiratory failure (SpO2 oxygen saturation \> 92% at room temperature).
- No arrhythmia, no intracardiac thrombus or vascular wall, no heart failure, LVEF ≥ 45%
- Blood test:
- Absolute neutrophil count (ANC) ≥ 1,000/mm3 (1 G/l) without filgrastim
- Absolute lymphocyte count ≥ 100/mm3 (0.1 G/l)
- Absolute platelet count ≥ 75,000/mm3 (75 G/l)
- Hemoglobin ≥ 8.0 g/dl
- Positive for CD19 measured by immunohistochemistry or flow cytometry.
- Agree to participate in the study
- Agree to use safe methods of contraception for female patients.
- Exclusion criteria:
- Involved central nervous system invasion at the time of screening.
- Medical history of veno-occlusive disease (VOD).
- Required acute treatment due to tumors such as intestinal obstructions, vascular compression, or respiratory failure.
- Having active hemolytic anemia.
- Diagnosed with primary immunodeficiency.
- Medical history of autoimmune neurological diseases or neuromyelitis.
- Receiving immunosuppressive medication, except for ≤ 30 mg prednisolone or equivalent at the time of CAR-T-cell transfusion.
- Having acute, progressive, or chronic graft-versus-host disease (GvHD).
- Having active infectious diseases determined by clinical, imaging, or other laboratory tests (blood culture, PCR, etc.)
- Patients who are critically ill or at risk of premature death characterized by:
- Acute liver failure requiring dialysis
- Heart failure requiring vasopressors
- Systemic infection unresponsive to antibiotics
- ECOG performance status ≥ 3 points at the time of screening
- Having other severe concomitant diseases (e.g., uncontrolled arterial hypertension, heart failure NYHA III-IV).
- Unstable angina within 3 months prior to screening.
- Any previous or concurrent malignancy was not B-cell lymphoma or B-ALL.
- Medical history of clinically relevant central nervous system disease, such as epilepsy, convulsions, paralysis, aphasia, uncontrolled cerebrovascular disease, traumatic brain injury, and Parkinson's disease.
- Intolerance to excipients from cellular products.
- Pregnant women or those who expect to be pregnant or reastfeeding.
- Other diseases or other conditions and circumstances that, according to the investigator's assessment, make it difficult to ensure compliance with study treatment.
- Participation in another clinical trial at the time of screening
Exclusion
Key Trial Info
Start Date :
August 2 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 31 2025
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT06027957
Start Date
August 2 2023
End Date
July 31 2025
Last Update
August 26 2025
Active Locations (1)
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1
Vinmec Research Institute of Stem Cell and Gene Technology
Hanoi, Hanoi, Vietnam, 100000